China's Pesticide Export Rules Set to Ease: A Look at the 2025 Draft Reforms

Existing Rules

Draft for Public Consultation

Influence

I. Scope of Application for Export-Only Pesticide Registration

For products that have obtained pesticide registration or import permits from the importing country (region) overseas, pesticide manufacturers may apply for export-only pesticide registration if they meet one of the following conditions.

(i) The company has already obtained technical material registration in China and is applying for registrations of the same active ingredient with different contents.

Explanation: This item applies to technical concentrates for which no technical material has been registered.

(ii) The company has already obtained registration for the technical material or single-active ingredient formulation of this active ingredient in China, and is now applying for registration of single-active ingredient formulations with different contents and dosage forms of the same active ingredient.

(iii) The company has obtained registration for mixed preparations in China and is applying for registration for mixed preparations with the same active ingredient but different contents, different ratios and different dosage forms.

If the amount of active ingredients in a mixed formulation exceeds the provisions of Article 8 of the "Regulations on the Registration and Management of Pesticides", the excess active ingredient shall be registered within the territory.

(iv) Applications for registration of active ingredients and their formulations by new pesticide technical manufacturers.

Explanation: 1. New pesticide technical materials and formulations can be registered simultaneously, or technical material registration can be applied for first, followed by formulation registration. 2. Enterprises that have obtained export-only registration for new pesticide technical materials can apply for export-only registration for single-component or mixed formulations containing the active ingredient, in accordance with the requirements for new pesticide formulations. Other active ingredients in mixed formulations should already be registered domestically. 3. For enterprises that have previously obtained domestic pesticide registration but no longer have products with valid registration, the original technical material manufacturer can apply for export-only registration, referring to the requirements for new pesticides.

(v) Other circumstances as stipulated by the Ministry of Agriculture and Rural Affairs.

I. Pesticide manufacturers holding certificates permitting overseas use and meeting one of the following conditions may apply for registration of their products as pesticides intended for overseas use only.

(i) If the active ingredient has not been registered for use in China, the applicant may apply for registration of the technical material (technical concentrate) and the formulation for pesticide overseas use only at the same time, or apply for registration of the technical material (technical concentrate) first and then apply for registration of the formulation.

(ii) If the active ingredient has been registered for domestic use as technical material, the registration certificate holder may apply for pesticide overseas use-only registration for technical material or technical concentrate with different contents of the active ingredient; if the active ingredient has been registered for domestic use as technical material, the registration certificate holder may apply for pesticide overseas use-only registration for technical material with different contents of the active ingredient.

(iii) If the active ingredient has already obtained domestic use registration, the applicant may apply for overseas use-only registration of a single formulation of the active ingredient or a mixed formulation containing the active ingredient, without being subject to the restrictions of Article 8 of the "Measures for the Administration of Pesticide Registration" and the provisions of Announcement No. 345 of the Ministry of Agriculture and Rural Affairs regarding pesticide content, ratio and quantity of active ingredients.

If the product contains a valid ingredient within the protection period of the registered information, the applicant must obtain the consent of the first registered certificate holder.

(iv) Other circumstances stipulated by the Ministry of Agriculture and Rural Affairs.

1. Registration requirements for pesticide formulations intended only for overseas use will be relaxed. As long as the active ingredient is registered domestically, pesticide manufacturers will be able to apply for registration of either a single formulation containing that active ingredient or a mixture containing that active ingredient. It will no longer be necessary for the active ingredient to be registered by the manufacturer to be eligible for formulation registration, and additional active ingredients in a mixture will not necessarily need to be registered domestically. However, it should be noted that if similar formulations have already been approved for domestic use, registration for pesticide formulations intended only for overseas use will no longer be approved. For already approved formulations, registration will be renewed no more than once.

2. Pesticide manufacturers that have previously obtained domestic pesticide registration but no longer have any products with a valid registration will be able to apply for pesticide registration for overseas use only, and pesticide manufacturers will no longer be considered original pesticide manufacturers.

3. To protect the first registered product, which is under data protection, the applicant will be required to obtain the consent of the first registration certificate holder.

4. The original document's provisions on “new pesticide” will be revised to “the active ingredient has not been registered for use in China” and allow companies to apply for overseas use-only registration. Overseas use-only registration for new pesticides will no longer be exclusive; multiple companies will be able to apply for overseas use-only registration before the active ingredients obtain domestic use registration.

II. Documentation Requirements for Application for Export-Only Non- New Pesticide Registration

(i) Pesticide registration application form (export only).

(ii) Valid overseas registration or import permit from the importing country (region) (if the permit does not match the name of the applicant company, convincing evidence of business cooperation should be provided).

Explanation: 1. "Supporting documents" refer to photocopies of overseas registration certificates or import licenses issued by overseas pesticide regulatory authorities. Registration certificates must include a label. 2. If the applicant is a supplier to the holder of an overseas pesticide registration certificate or import license, but this is not stated on the certificate, certification from the pesticide regulatory authority or notary office of the country (region) where the overseas registration or import license is issued is required, or the certification procedures stipulated in the relevant treaties between China and that country (region) must be fulfilled. Additionally, a supply contract or agreement signed between the applicant and the holder of the overseas registration certificate or import license should also be provided.

(iii) A commitment letter from the enterprise that it will not sell or use the product within the country (signed by the legal representative and stamped with the company seal).

(iv) Product overview, summary of overseas registration information, explanation of the source of raw materials, and other relevant materials.

(v) Product chemical data (product quality standards, quality analysis reports, and for technical materials, a full component analysis report) and toxicological experiment data (acute oral, dermal, and inhalation toxicity test reports), as well as information on poisoning symptoms, first aid, and treatment measures.

Explanation: First, the requirements for the "Experiment Report" and the qualifications of the experiment agency are consistent with the domestic registration requirements. For compliant overseas GLP reports, the transitional policy for registration materials will apply until the end of 2020. Second, the "Information on Poisoning Symptoms, First Aid, and Treatment Measures" can be accessed through online resources.

(vi) A copy of the pesticide production license that is consistent with the scope of production of the applied product.

II. The following documents should be provided when applying for registration of pesticides intended for overseas use only.

(i) Pesticide registration application form.

(ii) Product registration information.

1. Product overview, summary of overseas registration information, description of the source of the active ingredient, Material Safety Data Sheet (MSDS), and other relevant materials.

2. Product chemical information.

2.1 For technical material/concentrate unregistered for domestic use, provide: physico-chemical properties of the active ingredient and its technical material/concentrate, 5-batch test reports, Chinese generic name confirmation letter, and reference standards substances.

2.2 For technical material that have obtained domestic use registration, a full component analysis report shall be provided; for technical concentrate and formulations, product quality standards and quality analysis reports shall be provided.

3. Toxicological data: For the technical material, reports on acute oral, dermal, and inhalation toxicity experiments, as well as information on poisoning symptoms, first aid, and treatment measures, should be provided. For the technical concentrate and formulation, information on poisoning symptoms, first aid, and treatment measures should be provided.

(iii) A copy of the pesticide production license (the production scope should cover the corresponding active ingredients or formulations).

(iv) Commitment letter not to sell or use within the territory (signed by the legal representative and stamped with the company seal).

(v) Permitting the use of supporting documents by overseas entities.

1. If the corresponding product is managed as a pesticide overseas, a pesticide registration certificate (overseas pesticide registration certificate) from the destination country (region) should be provided. For formulation products, a label should also be attached.

If the applicant is a supplier of a pesticide registration certificate holder overseas, they should provide proof issued by the overseas pesticide registration certificate issuing authority, or a copy of the relevant supply contract and overseas notarized documents.

2. If the corresponding products are not managed as pesticides overseas, an import consent document from the destination country (region) should be provided.

1. If the active ingredient has not obtained domestic use registration, or if the pesticide name is not in the list of generic pesticide names in China, a Chinese generic name naming letter is required (currently handled by the Institute for the Control of Agrochemicals, Ministry of Agriculture and Rural Affairs).

2. The toxicological data requirements for the registration of technical material have been significantly reduced. Only acute oral, dermal, and inhalation toxicity experiment data are required, just like the requirements for formulations. No other toxicological data is required, which greatly reduces the registration experiment costs for enterprises.

3. Strict requirements for pesticide production licenses: The draft for comments stipulates that the production scope must cover the corresponding active ingredient or formulation. This is unreasonable in CIRS opinion, as companies applying for new pesticide production licenses are not allowed to apply for licenses before obtaining the registration certificate. The original document requirements for new active ingredients included copies of the environmental impact assessment and safety production evaluation approval documents for the technical material.

4. Further refine the requirements for overseas registration documentation.

III. Documentation Requirements for Applying for Registration of New Pesticides for Export Only

For applications for registration of new pesticide technical materials limited to export, in addition to providing the information required for non-new pesticide registration (items (i) to (v)), the following information shall also be provided:

(i) Physicochemical properties of active ingredients and technical material, as well as standard substances.

(ii) Abstracts or reference materials of tests on the skin irritation, eye irritation, skin sensitization, acute neurotoxicity, subchronic oral toxicity, subchronic (acute) dermal and inhalation toxicity, mutagenicity, teratogenicity, two generations of reproductive toxicity, chronic and carcinogenicity, metabolism and toxicokinetics of the active ingredient.

(iii) A photocopy of the environmental impact and safety production evaluation approval document for the active ingredient.

For applications for registration of new pesticide formulations limited to export, the required documents should be provided in accordance with the registration requirements for non-new pesticides.

IV. Other

(i) Pesticides for export only shall be processed in accordance with the application and approval procedures for pesticide registration, registration change, and registration renewal. The pesticide registration certificate number code shall be “EX + year + serial number”, such as EX20200001. The pesticide registration certificate shall indicate “For export only ”.

Explanation: 1. The registration procedure for pesticides designated for export only is consistent with the relevant regulations for domestic pesticide registration, with a processing time of 20 working days (technical review time not exceeding 6 months). 2. Pesticides registered for export only are reviewed by the Executive Committee of the National Pesticide Registration Review Committee. 3. The registration certificate for pesticides designated for export only is valid for 5 years. 4. If the country (or region) where a pesticide designated for export only is registered changes, an application for registration modification can be submitted. 5. When renewing the registration of pesticides designated for export only, it is necessary to verify the changes in the product's domestic and overseas registrations.

(ii) If the same or similar formulations have already been registered in China, the pesticide product will no longer be approved for export-only registration, and the registration of the approved application will be extended no more than once.

Explanation: 1. Once a new pesticide obtains domestic registration, no other company will be granted export-only registration for pesticide products containing the same active ingredient. Existing export-only registrations can be renewed once. 2. Once a non-new pesticide-similar formulation obtains domestic registration, no other pesticide product will be granted export-only registration. Existing export-only registrations can be renewed once.

(iii) For applications for registration of technical concentrateonly for export, the applicant must be the manufacturer of the technical concentrate 's active ingredient, and the required documentation is the same as that for the formulation.

(iv) If a new pesticide technical material registration is obtained that is only for export, it may be produced and exported only after obtaining the corresponding production license.

(v) Export-only pesticide products can only be exported to countries (regions) that have obtained overseas registration or import approval.

(vi) It is prohibited to sell pesticide products that are only for export within China. Violators will be dealt with in accordance with the relevant provisions of the Pesticide Management Regulations on failure to obtain domestic use registration.

(vii) This announcement shall take effect from the date of its issuance.

III. For applications to change the registration of pesticides intended for overseas use only, the "Requirements for Pesticide Registration Materials" shall be followed. If an export destination country (region) is added, the corresponding certificate of permission for overseas use shall also be submitted.

IV. For applications for renewal of pesticide registration for use only overseas, the procedures outlined in the "Requirements for Pesticide Registration Documents" shall be followed, and a valid certificate permitting overseas use shall be submitted.

If similar formulations have already been approved for domestic use, no further registration of the corresponding formulations for pesticides intended solely for overseas use will be approved; for those already approved, registration may be extended no more than once.

For pesticide overseas use-only registration certificates which the active ingredient has not obtained domestic use registration, the renewal of such registration certificate after the active ingredient obtains domestic use registration shall not exceed once, except for the holder of the first domestic use registration certificate for the active ingredient.

V. Other provisions.

(a) The technical review period for the registration and registration change of pesticides intended for use abroad is six months.

(ii) The registration certificate number for pesticides intended for use abroad only is “EX + year + four-digit serial number”, and the pesticide registration certificate shall indicate “ For overseas use only” and the abbreviation of the country (region) intended for overseas use only .

(iii) Pesticides registered for use only overseas can only be exported to the country (region) specified in the corresponding registration certificate, except for those that have been converted to pesticide registration for use only overseas in accordance with the relevant announcement.

(iv) Pesticides registered for use only overseas are not permitted to be outsourced for processing. Any business operating within China that uses pesticides registered for use only overseas is to be treated as dealing with counterfeit pesticides.

We are now soliciting opinions on the above measures. Please submit your opinions in writing or by email to the Department of Crop Production Management of the Ministry of Agriculture and Rural Affairs before November 21, 2025.

1. Protection for the first company to obtain domestic registration: The number of times a pesticide registration can be renewed for use overseas will not be affected. Other companies can only renew once. If they want to reapply, they must obtain consent from the first company.

2. The labeling on the pesticide registration certificate will be changed from "Export Only" to "For Overseas Use Only" + the abbreviation of the country (region) for overseas use only;

3. The government may directly change the registration of some banned or restricted pesticides from PD certificates to pesticides registered for overseas use only. These products are not restricted to specific export countries.

4. Pesticides registered for overseas use only will not be permitted to be outsourced for processing.

Explanation:

Paraquat and other herbicides, which were originally registered exclusively for export, were converted to export-only registration upon registration renewal.

National regulations stipulate that no new highly toxic or extremely toxic pesticides will be registered within the country, and export-only registrations will not be granted. The prohibition and restriction of pesticide products in China must be strictly implemented in accordance with the requirements of the prohibition and restriction announcements.

Applications for highly toxic and extremely toxic pesticides will be removed. Whether applications for pesticide registration for overseas use only are still pending official clarification regarding highly toxic and extremely toxic pesticides remains to be clarified.